Regulatory Affairs & Quality Assurance Manager

DOCUMENTATION

• Ensures that all pertinent documents are available for FDA inspection
• Compile and maintain complete technical data of each product.
• Develop and maintain Standard Operating Procedures (SOPs)
• Direct and monitor the preparation and real-time submissions of License to Operate, Cosmetic Notifications, CPRs renewal applications, reports, or other related regulatory correspondence.
• Oversee documentation efforts to ensure compliance with FDA regulations and standards.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.

OPERATIONS

• Provide responses to regulatory agencies regarding product information or issues.
• Maintain current knowledge of relevant regulations and keeping up to date with changes in regulatory legislation and guidelines.
• Manage activities such as audits, FDA inspections, or product recalls.
• Participate in the development or implementation of product testing protocols.
• Provide regulatory guidance to related departments or product development team regarding ingredients, label design, development, evaluation, or marketing of products.
• Communicate regulatory information to other departments and ensure that information is interpreted correctly.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
• Contribute to the development or implementation of strategic and operating plans.
• Conducts trade checking / claim surveillance activity as scheduled.Coordinate and monitor the destruction and disposal of rejected, damaged, or expired finished product and components.
• Ensuring that all products released to the market possess the quality required for their intended purpose, complies with GMP requirements, and consistent with the regulatory filings at the time of release and throughout shelf-life.
• Ensuring that all third-party suppliers, if any, comply with applicable GXP requirements (GMP for the TPC, GLP for the TPL, and GSP and GDP for the LSPs) and LMI Quality Standards.

SUPPLIERS

• Assigned to handle products from China suppliers.
• Conduct annual Suppliers and Toll Manufacturing audits.
• Coordinate with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
• Updating of product information file of all cosmetics products from China Suppliers.
• BSCI and Technical Audit monitoring of OBQA suppliers.

CUSTOMER RELATIONS

• Conducts and investigate product complaints and assists in answering customer inquiries.
• Implement or monitor complaint handling to ensure effective and timely resolution of all complaint investigations.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

TEAM MANAGEMENT

• Update related departments and the Management on latest regulatory requirements and FDA advisories.
• Conduct meeting within the team for progress and updates.
• Train team members in regulatory policies or procedures.
• Establish regulatory priorities or budgets and allocate resources and workloads. Set weekly target for the team.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Evaluate performance of each team member.
• Prepare and send monthly topics for discussion to the management.

OTHERS

• Perform other related duties as required by FDA and other tasks assigned as needed.

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